Post Approval Monitoring Regulatory Mandates

Research Involving Human Subjects

Institutions that hold an OHRP Federalwide Assurance are required to have procedures “that include formal mechanisms for monitoring compliance with human subject protection requirements.”

The following provisions of the Common Rule are currently interpreted as granting the institution, the IRB, and/or its representative(s) the authority and responsibility to audit research.

  • 45 CFR 46.109 (e)

An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

  • 45CFR46.111 (a) (6)

(The IRB is also required) to ensure that when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

Research audit programs provide one mechanism for ensuring compliance with these requirements.

Sources:
Office for Human Research Protections. Regulations: Protection of Human Subjects
Institutional Review Board Management and Function, Bankert and Amdur

Research Involving Vertebrate Animals

Both the Animal Welfare Act and the Public Health Service (PHS) Policy require the institutional animal care and use committee (IACUC) to provide oversight of the animal program through continuing reviews to ensure that procedures are performed as approved by the committee.

A variety of mechanisms can be used to facilitate ongoing protocol assessment and regulatory compliance. Post-approval monitoring (PAM) is considered in the broadest sense, consisting of all types of protocol monitoring after the IACUC's initial protocol approval.
PAM helps ensure the wellbeing of the animals and may also provide opportunities to refine research procedures. Methods include continuing protocol review; laboratory inspections (conducted either during regular facilities inspections or separately); veterinary or IACUC observation of selected procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments. The IACUC, veterinary, animal care, and compliance staff may all conduct PAM, which may also serve as an educational tool.

Sources:
Guide for the Care and Use of Laboratory Animals; Eighth Edition
Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals
Animal Welfare Act; U.S. Department of Agriculture (USDA)